About
Zinc is an essential trace mineral that participates in over 300 enzymatic reactions and is critical for immune function, protein synthesis, wound healing, DNA synthesis, and cell division. It is added to foods as a fortification nutrient or included in dietary supplements in various salt forms such as zinc gluconate, zinc sulfate, zinc oxide, and zinc citrate.
Safety summary
Zinc is safe and essential at recommended intake levels, but chronic excessive supplemental intake (≥50 mg/day over weeks) can cause zinc-induced copper deficiency, anemia, neutropenia, and suppressed immune function. EFSA sets a Tolerable Upper Intake Level (UL) of 25 mg/day for adults, while the US FDA/IOM sets the UL at 40 mg/day; WHO dietary reference values range from 6.7 to 15 mg/day. Infants, young children, and those with renal impairment are particularly sensitive to excess intake.
Regulatory landscape
| Jurisdiction | Status | Note |
|---|---|---|
| FSANZ (Food Standards Australia New Zealand) (Australia) | Approved | Zinc is approved as a permitted mineral for addition to food under the Australia New Zealand Food Standards Code; UL aligns with IOM reference of 40 mg/day for adults.source |
| EFSA (European Food Safety Authority) (European Union) | Approved | EFSA established a Tolerable Upper Intake Level (UL) of 25 mg/day for adults. Population Reference Intake (PRI) for men ranges from 9.4 to 16.3 mg/day and for women 7.5 to 12.7 mg/day, varying by dietary phytate level. Various zinc salts (acetate, bisglycinate, chloride, citrate, gluconate, lactate, pidolate, picolinate) are approved for food supplements only.source |
| FSSAI (Food Safety and Standards Authority of India) (India) | Approved | Zinc is permitted as a nutrient in health supplements and nutraceuticals under the Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations, 2016. Also permitted for food fortification (e.g., in wheat flour) per FSSAI fortification standards; dietary standards follow ICMR RDA (12 mg/day for adult men, 10 mg/day for adult women).source |
| FDA (Food and Drug Administration) (United States) | Approved | The Tolerable Upper Intake Level (UL) for adults is 40 mg/day; for infants, children, and adolescents it ranges from 4 to 34 mg/day depending on age. RDA is 11 mg/day for men and 8 mg/day for women. Zinc is recognized as an essential nutrient and is permitted as a food fortification and dietary supplement ingredient under 21 CFR. |
Who should approach with care
Research citations
- 1other. Zinc – Health Professional Fact Sheet. ods.od.nih.gov
- 2PubMed. Zinc Toxicity: Understanding the Limits, 2024. pmc.ncbi.nlm.nih.gov
- 3PubMed. Reconsidering the Tolerable Upper Levels of Zinc Intake among Infants and Young Children: A Systematic Review of the Available Evidence, 2022. pmc.ncbi.nlm.nih.gov
- 4FSSAI. Food Safety and Standards (Health Supplements, Nutraceuticals, Food for Special Dietary Use, Food for Special Medical Purpose, Functional Food and Novel Food) Regulations — Compendium 2021, 2021. fssai.gov.in
- 5EFSA. Scientific Opinion on Dietary Reference Values for zinc, 2014. efsa.onlinelibrary.wiley.com